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Failure to validate the design of its AED batteries, lax complaint handling procedures and numerous other quality system repeat observations resulted in a warning letter for AED maker Zeller Power Products following a Nov. 6-9, 2018 inspection of its Wallace, Idaho facility. The FDA said the firm’s response to the Form 483 was not acceptable. Read More
Failure to document re-worked nonconforming products and to establish procedures for controlling process parameters were just a few of the many quality system failures documented in a May 13 warning letter to devicemaker Orchid Orthopedic Solutions following a Feb. 4-15 inspection of its Holt, Michigan plant. Read More
Complaint records at the Singapore-based firm were found to be deficient in that they didn’t include findings and trend analyses, and CAPA procedures were not initiated. Read More
The investigator found that Orchid Orthopedic failed to regularly analyze rework shop orders as a source of quality data to identify potentially recurring quality problems. Read More
“The firm's missing design plans were necessary to ensure that the supporting device test records submitted with the 510(k) were complete and accurate,” the FDA said. Read More
Although the firm identified the possible root cause as being either a design, manufacturing or unknown issue, it did not initiate a CAPA or supplier corrective action. Read More